Last week, a number of health care industry associations sent letters to Congress detailing ways in which the government could relieve them of the burdens associated with “red tape.” The letters are in response to the first stage of a House initiative dubbed the “Medicare Red Tape Relief Project,” which was announced earlier this summer by the House Committee on Ways and Means’ Subcommittee on Health. Continue Reading Hospitals and Others Respond to “Red Tape Relief Project” Requests

Although telehealth has the potential to improve or maintain quality of care for Medicare beneficiaries, payment and coverage restrictions create barriers that prevent providers from fully utilizing telehealth technologies. That is the core finding of a report issued by the Government Accountability Office (GAO) this month on telehealth and remote patient monitoring use for Medicare beneficiaries.

The GAO report was issued as part of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which included a provision for the GAO to study telehealth and remote patient monitoring. In compiling the report, the GAO interviewed representatives of nine provider, patient, and payor associations who provided feedback on, among other things, barriers to providing telehealth services to Medicare beneficiaries. Continue Reading GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption

In another procedural defeat for the Texas Medical Board (the “Board”) over its embattled telemedicine rule, last week, a federal judge held that the Board waited too long to request certification of appeal to the Fifth Circuit. Thus the Board’s existing appeal will move forward under the collateral-order doctrine. The Board’s brief is available here. Though this is a procedural setback for the Board, its appeal of the decision regarding its ability to escape antitrust liability under the state-action immunity doctrine is still pending before the Fifth Circuit.

As we have been closely following, in January 2015, the Board issued an “emergency” proposed rule requiring physicians to perform a face-to-face or in-person physical examination of a patient prior to issuing a prescription or risk sanctions for unprofessional conduct. Teladoc, Inc. and other Plaintiffs subsequently brought an antitrust claim against the Board alleging that the new regulation violates Section 1 of the Sherman Act and the Commerce Clause. The Board filed a motion to dismiss arguing (1) that the Board is entitled to state action immunity; (2) Plaintiffs’ claims were barred by the statute of limitations; and (3) Plaintiffs failed to state a claim under the Commerce Clause. A federal district court denied the Board’s motion to dismiss on all three grounds and specifically found that the Board is not entitled to state action immunity because its actions are not actively supervised by the state.

Last month, Jonathan Woodson, M.D., the Assistant Secretary of Defense for Health Affairs for the U.S. Department of Defense, issued a memorandum that effectively changes the Military Health System (“MHS”) policy on telemedicine. The new policy enables the MHS to treat patients via telemedicine when the patients are located in their homes or other locations “deemed appropriate by the treating provider.” Previously, similar to the originating site restrictions found in the current Medicare reimbursement laws, MHS providers could only treat patients via telemedicine if the patients were physically present at a military treatment facility or other designated facility, which did not include the patient’s home.

The memorandum notes that one of MHS’s major focus areas over the past year has been promoting additional options for accessing care. And the Assistant Secretary has been an outspoken advocate for expanding telemedicine services in the MHS. For example, during the keynote speech at the American Telemedicine Association’s 2014 conference, he noted that as care standards continue to evolve, it’s imperative that the MHS embrace telehealth. Continue Reading U.S. Department of Defense Expands Telemedicine Access for Military Members

As the year winds down, we look back on the significant developments in telemedicine in 2015 as well as look forward to what 2016 will bring. The number of providers offering telemedicine and telehealth services dramatically increased in 2015, with no sign of slowing in 2016. This is, in large part, due to state lawmakers’ attempts to remove or ease common barriers to telemedicine expansion – including licensure and reimbursement. States continue to sign on to the interstate medical licensure compact, and more states are requiring commercial insurers to cover telemedicine services on par with in-person services. Not to be left out, Congress introduced several bills in 2015 that seek to expand the use of telemedicine for Medicare beneficiaries, and we expect a fourth telemedicine bill to be introduced early in 2016 that would address Medicare coverage and reimbursement. Additionally, many state legislatures and/or state medical boards issued more detailed standards for the provision of online treatment and prescribing, which decreases the uncertainty of state laws in this area and paves the way for providers to tailor their telemedicine programs to fit within state laws. Listed below are four important developments in telemedicine for 2015 and our prediction of trends in 2016. Continue Reading Telemedicine – 2015 Year in Review

A federal district court denied the Texas Medical Board’s (the Board) motion to dismiss an antitrust suit filed by a telemedicine company (Teladoc), finding that the Board is not entitled to state action immunity because its actions are not actively supervised by the state. Teladoc, Inc. v. Texas Medical Board, No. 1-15-cv-343 (W.D. Tex Dec. 14, 2015) (order denying motion to dismiss). As we previously reported, the Board issued an emergency rule in January attempting to amend its telemedicine regulations to mandate a “face-to-face visit or in-person evaluation” prior to a physician issuing a prescription. The Board then engaged in a formal rulemaking to adopt the amendment in April. Teladoc won a preliminary injunction in May, temporarily blocking the implementation of the new rule. Continue Reading Antitrust Suit Continues to Stymie New Texas Telemedicine Regulation

On June 29, 2015, the American Academy of Pediatrics (AAP) published a policy statement supporting the use of telemedicine in the practice of pediatrics as long as telemedicine technologies are used “in support of and integrated with” the patient-centered medical home (PCMH) – not in place of it.

In its first statement on telemedicine, the AAP’s Committee on Pediatric Workforce expressed concern related to the increased use of telemedicine by virtual providers who provide healthcare services to patients via smart phone, laptop or video-consultations without a previous physician-patient relationship, previous medical history, or hands-on physical examination. As noted by the committee members, such telemedicine services can undermine the basic principles of the PCMH model and thus there is a greater need for regulatory action on telemedicine from states and local governments. Continue Reading American Academy of Pediatrics Recommends Limits on Telemedicine

On July 7th, the House introduced much anticipated bipartisan telehealth legislation. The Medicare Telehealth Parity Act of 2015, introduced by Representative Mike Thompson (D-CA) and co-sponsored by Representatives Gregg Harper (R-MS), Diane Black (R-TN), and Peter Welch (D-VT), would gradually increase the scope of telehealth services covered by Medicare and addresses many of the current limitations in Medicare’s coverage of services provided to patients remotely.

Over a four-year implementation period, the bill, if enacted, would incrementally expand coverage for telehealth services by easing current limitations on coverage. Specifically, the bill would:

Expand the provider types whose services are covered to include certain allied health professions, including physical and occupational therapists and audiologists;

Expand the types of services that are covered to include services like audiology and outpatient therapy services;

Relax the “originating site” requirements for certain services;

Expand the geographic locations in which telehealth services are covered; and

On Monday, during the annual meeting of the American Medical Association (AMA) House of Delegates, the delegates voted to table a proposed measure to adopt ethical guidelines for physicians who provide telemedicine services. The proposed guidelines, which were based on recommendations by the AMA’s Council on Ethical and Judicial Affairs (CEJA), focused on issues such as ensuring patient privacy and educating patients on the limitations of telemedicine.

Associate Editors

Mintz Levin’s Health Law Practice

As the health care and life sciences industries continue to undergo sweeping regulatory change, your company might be facing unprecedented structural and operational challenges. Heightened government scrutiny of industry practices certainly adds to the complexity of operating in the market for all providers, payors, manufacturers, distributors, and suppliers.Read More